Quality Assurance Associate – Senior

Zenith LifeScience; Raleigh (NC); Hybrid; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Contractor Quality Associate in Raleigh, NC, to ensure data integrity and compliance in the biologics sector. This hybrid role combines the best of onsite collaboration and remote flexibility, allowing you to thrive in a fast-paced environment. Your expertise in data management, statistical analysis, and familiarity with bioanalytical methods will be crucial for supporting quality assurance processes. You will engage with cross-functional teams, author technical reports, and act as a subject matter expert on product-specific test methods. Join this innovative firm and contribute to impactful projects that prioritize patient safety and product quality.

Qualifications

• 4+ years in cGMP Quality Control within FDA-regulated industry.
• Familiarity with bioanalytical methods and data trending.

Responsibilities

• Data review and management for electronic systems.
• Monitor release and stability data for compliance and quality.

Skills

Data Management

Statistical Analysis

Communication Skills

Organization Skills

Technical Writing

Education

Associate Degree

Bachelor's in Life Sciences

Tools

Excel

Minitab

Veeva Quality Systems

JMP

Job description

Location: Raleigh, NC (hybrid role – 2 days onsite; 3 days WFH)

Duration: 12 Months

Job Description :

The Contractor Quality Associate, Biologics plays a critical role for data management of commercial biologics executed by contract laboratories.

The position requires familiarity with data review, data management in Excel or Minitab, and an understanding of LIMS systems. Some understanding or familiarity with bioanalytical methods such as, but not limited to, compendial, HPLC, ELISA, CE, real-time PCR, spectrophotometry, and SDS-PAGE is valuable.

The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.

Essential Functions :

• Data review and data management to support the use of electronic systems such as Veeva Quality eDocs and Minitab.
• Perform and support data trending, interpretation, and statistical analysis of commercial release and stability studies for assay controls or reference standards and invalid assay trending.
• Monitor release and stability data to ensure data integrity, regulatory compliance, product quality, and on-time completion.
• Act as the technical reviewer of data sets, quality records, and lab investigations generated by contract test labs.
• Author CoAs, technical reports, and internal quality records in accordance with regulatory requirements.
• Serve as the SME for product-specific test methods for internal and external quality control.
• Collaborate frequently with internal and external cross-functional groups to provide status updates, workflows, and timelines for routine testing activities, including CMOs/contract test labs, manufacturing operations, quality, regulatory, and program management.
• Monitor product-specific reference standard programs in collaboration with the network Analytical/Quality experts to sustain routine testing activities, including driving efforts for reference standard qualification, annual re-qualification, and distribution to contract test labs.
• Support analytical method validation and method transfer activities.

Requirements :

Education:

• Associate degree (required); BS/BA in pertinent life sciences or closely related field (preferred)

Technical:

• 4+ years of pharmaceutical/biotech working experience in a cGMP Quality Control, analytical development, analytical transfer, or validation department in an FDA-regulated industry.
• Familiarity with data trending and monitoring controls.
• Hands-on experience within a bioanalytical lab, including familiarity with equipment and test methods such as HPLC, CE, PCR, ELISA, gel-based assays, and other compendial assays used to test biopharmaceuticals.
• Familiarity with Method Validation, Analytical Transfers, or laboratory investigation experience.
• Thorough understanding of principles, practices, and standards for biopharmaceutical testing.
• Well-versed in ICH and regulatory requirements for quality as it relates to QC operations, laboratory compliance, data integrity, and quality events.
• Experience performing statistical analysis of data sets using software such as JMP or Minitab is a plus.
• Proficient in Microsoft Office tools, Minitab, and Veeva Quality systems.

Must Possess:

• Strong organization and communication skills along with technical writing skills.
• Self-directed, goal-oriented, and quality conscious.
• High attention to detail with the ability to rapidly see the big picture and assess the impact of data and/or decisions.
• Values consistent with Company Values (Integrity, Respect, Professionalism, Quality, and Teamwork), along with an intrinsic understanding of the Company’s Mission and the need to always think first of the Patient.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Quality Assurance

Industries

• Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing